The UK’s Food Standards Agency (FSA) has issued its first positive safety assessment for a consortium application in its CBD Novel Foods approval process, seeing the European Industrial Hemp Association’s (EIHA) RP427 application progress to the ‘risk management’ phase.
Coming just months after the first two individual applications were given positive risk assessments in May, this represents another major step forward for the UK CBD industry’s arduous journey towards full regulation.
EIHA’s RP427 application represents over 160 companies from across the UK, Europe and the US, and includes over 1000 products.
Given the complexities of attempting to approve hundreds of products at once, a strategy that was initially not allowed by the regulation, EIHA aimed to standardise the entire procedure, imposing strict guidelines on the starting material and extraction methods.
EIHA’s Managing Director, Lorenza Romanese, told Business of Cannabis: “It’s easier to pass one product, but it is not the same to standardise 160 companies on the market that do not speak the same language. So it required a lot of effort to sit down with partners and standardise their products.
“We made a huge effort to standardise the processes among the members of the consortium to ensure they were abiding by the stringent rules that make them compliant with what we have tested.”
EIHA Board Member and UK Representative, Tony Reeves said “This is indeed excellent news for our sector and a milestone moment not just for our EIHA members but for the market in general as it represents a real potential to boost consumer trust in the category, enhance retailer confidence and provide a catalyst for investment in the industry.”
What is included?
In October last year, the FSA published a shock update to its consumer guidance on the recommended daily dosage of CBD.
According to new ‘scientific evidence’, understood to have been gained from toxicological studies submitted by the industry itself, the FSA dropped its recommended daily intake (ADI) from 70mg a day to just 10mg a day.
Given that hundreds of companies had already completed their dossiers and submitted them to the FSA, this late stipulation caused significant complications for swathes of the sector and raised concerns of consumer mistrust in the industry due the limited efficacy of CBD at these levels.
With both of the previously passed applications falling within this threshold, many took this as confirmation that the 10mg limit was a prerequisite for applications to pass.
According to EIHA, however, their application supports an ADI of 17.5mg a day ‘for six weeks’, while the FSA recommanded an ADI of 10 mg a day lifelong.
In their assessment, the “Committee (ndr ACNFP) concluded that the applicant had provided sufficient information to assure the novel food, an isolated CBD as detailed in application RP427, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods and food supplements was not considered to be nutritionally disadvantageous”.
Ms Romanese explained: “We submitted what the science revealed, meaning an ADI of 17.5mg a day. The FSA presented a provisional ADI of 10mg every day, our ADI is 17.5mg and the food supplement should be taken fr a period of 6 weeks, which in the long run is probably even more conservative.”
The FSA are expected to give their final verdict on this ADI in the next ‘risk management’ phase.
EIHA’s CBD Consortium Application Clears First Hurdle with FSA Approval
EIHA explained that the guidelines given to its members in order for them to adhere to its standardisation include a starting material of industrial hemp grown from varieties listed in the European catalogue.
Each oil product must use natural (non-synthetic) CBD extract in any vegetable oil, extracted using traditional methods of extraction as per EU directives.
The association said in a statement: “The classification not only underscores our commitment to safety and compliance but also provides substantial benefits to EIHA members. The dossier supporting this classification was founded on toxicological data paid for by EIHA members, which has been granted confidentiality for a period of five years.
“As a result, only EIHA members have the exclusive right to market these products under this classification. This exclusivity is critical as it ensures that only those who have contributed to the research and complied with stringent standards can benefit, preventing free riders from capitalizing on the efforts without having invested in the process.”
Long awaited progress
The risk assessment stage marks the latest significant step forward in the approval process, which has kept the industry in limbo since 2021.
After publishing the ‘public list’ of validated CBD applications in June 2022, which allowed companies that had submitted complete dossiers to the FSA to continue to trade, those included moved to the ‘risk assessment’ phase.
This phase, widely considered to be the toughest part of the approval process, sought to establish whether these CBD novel foods are safe under the proposed condition use submitted by each applicant.
In May, 2024, following over a year with no meaningful progress, the FSA announced that Chanelle McCoy’s subsidiary, Pureis, and Cannaray received the first ever positive risk assessments for their applications.
Earlier this week, EIHA announced that its consortium, created in 2019, had also moved to the next stage, seeing the number of products which could potentially be fully approved for sale in the UK rise dramatically.
Ms Romanese explained: We should always recall that when we started the consortium back in 2019, joint applications were forbidden. So I really think that we have to acknowledge the bravery and the long term vision of the EIHA board.
“It does not make sense to kill millions of rats and spend so much money, so we said let’s join forces. Now we have the first consortium, probably representing the biggest share on the market, that has achieved a positive risk assessment.
“But the battle is not over yet, we still need to move our full spectrum application through the risk assessment stage and both need to be approved in Europe.
When questioned about the passage of EIHA’s application, a spokesperson for the FSA said that the safety assessment had not yet been published, and that they would only comment once it was publicly available.
Now that the products have made it through the risk assessment process, they’ll move onto the risk management phase.
According to the FSA, this will consider ‘other legitimate factors in its use like labelling considerations; and a public consultation prior to sending advice to ministers across the nation on whether to authorise.’
